The Erlanger Stroke Registry (ESPro) is the Only Ongoing Prospective Population-based Stroke Registry in Germany, Started in 1994. ESPro Includes All Hospitalized and Non-hospitalized Patients With Stroke in the Community of Erlangen (120.000 Inhabitants), With a Long-life Follow-up. (ESPro)
The Erlangen Stroke Registry (ESPro)
Stroke is a disease that primarily affects older adults and, with an estimated 64,000 deaths in 2024, is one of the leading causes of death in Germany. Estimates of its prevalence and the burden of disease within the German population are therefore essential for calculating future healthcare needs and guide health policy planning. When the first stroke units (SU) began to emerge in Germany in 1994, health insurers raised the question of the total number of stroke patients requiring care. Unfortunately, at that time there were no reliable figures available to determine the nationwide need for stroke units. This marked the birth of the Erlangen Stroke Registry (ESPro).
For 32 years (1994-2026), ESPro has been continuously collecting data on the epidemiology, clinical course, and care of stroke and dementia, two of the most common diseases. The ESPro is designed as a regional, population-based registry that includes, as far as possible, all diagnosed strokes-that is, both hospitalized and non-hospitalized patients-regardless of age group or severity of the condition. Patients enrolled in the city of Erlangen undergo close monitoring of their clinical course and are followed up at intervals of 3 and 12 months, and then annually for the rest of their lives. This long-term follow-up enables comprehensive health services research on stroke, a widespread disease. Direct information on the course of the disease, its treatment, and care can be gleaned from registry data and incorporated into preventive medicine, treatment, and care planning.
調査の概要
状態
研究の種類
入学 (推定)
連絡先と場所
研究連絡先
- 名前：Peter L. Kolominsky-Rabas, Univ.-Prof. Dr. med.
- 電話番号：+49 9131 85-35855
- メール：peter.kolominsky-rabas@fau.de
研究場所
-
-
-
Erlangen、ドイツ、91054
- 募集
- Universitätsklinikum Erlangen
-
Erlangen、ドイツ、91054
- 募集
- Malteser Waldkrankenhaus St. Marien
-
Erlangen、ドイツ、91056
- 募集
- Klinikum am Europakanal
-
-
参加基準
適格基準
就学可能な年齢
健康ボランティアの受け入れ
受講資格のある性別
サンプリング方法
調査対象母集団
The Erlangen Stroke Project (ESPro) is a community-based survey of all cases of stroke occurring in a university town, located in Bavaria in Southeast Germany. Several overlapping sources of information were used to ensure complete case ascertainment: (1) hospital admission and discharge lists and computer-linked records systems; (2) regular checks of all relevant hospital wards and residential and nursing homes; (3) records of ambulance and emergency services; (4) GPs; and (5) death certificates.
説明
Inclusion Criteria:
- All cases of stroke defined according to WHO criteria, as "rapidly developing clinical symptoms and/or signs of focal, and at times global, loss of cerebral function, with symptoms lasting more than 24 hours or leading to death, with no apparent cause other than that of vascular origin occurring in Erlangen, Bavaria
- No restrictions regarding age (provided they are of legal age), socioeconomic circumstance, stroke severity, or prior health status
Exclusion Criteria:
- Patients with transient episodes lasting less than 24 hours and those with asymptomatic lesions detected by brain imaging ("silent infarcts")
研究計画
研究はどのように設計されていますか？
デザインの詳細
- 観測モデル：COHORT
- 時間の展望：PROSPECTIVE
コホートと介入
グループ/コホート |
|---|
|
People with stroke
All individuals diagnosed with stroke (both hospitalized and non-hospitalized) |
この研究は何を測定していますか？
主要な結果の測定
結果測定 |
メジャーの説明 |
時間枠 |
|---|---|---|
|
性別
時間枠：ベースライン
|
ベースライン
|
|
|
教育
時間枠：ベースライン
|
ベースライン
|
|
|
Postal code
時間枠：Baseline
|
Baseline
|
|
|
Name
時間枠：Baseline
|
Baseline
|
|
|
Address
時間枠：Baseline
|
Baseline
|
|
|
Telephone number
時間枠：Baseline
|
Baseline
|
|
|
Nationality
時間枠：Baseline
|
Baseline
|
|
|
Employment status
時間枠：Baseline, after 3 months, after 12 months, then annually until the end of the study. Currently there is a follow-up of 32 years
|
Baseline, after 3 months, after 12 months, then annually until the end of the study. Currently there is a follow-up of 32 years
|
|
|
Marital status
時間枠：Baseline, after 3 months, after 12 months, then annually until the end of the study. Currently there is a follow-up of 32 years
|
Baseline, after 3 months, after 12 months, then annually until the end of the study. Currently there is a follow-up of 32 years
|
|
|
Number of children
時間枠：Baseline, after 3 months, after 12 months, then annually until the end of the study. Currently there is a follow-up of 32 years
|
Baseline, after 3 months, after 12 months, then annually until the end of the study. Currently there is a follow-up of 32 years
|
|
|
Name of the health insurance company
時間枠：Baseline, after 3 months, after 12 months, then annually until the end of the study. Currently there is a follow-up of 32 years
|
Baseline, after 3 months, after 12 months, then annually until the end of the study. Currently there is a follow-up of 32 years
|
|
|
Length of residence in the study area
時間枠：Baseline
|
Baseline
|
|
|
Telephone number of the General practitioner
時間枠：Baseline, after 3 months, after 12 months, then annually until the end of the study. Currently there is a follow-up of 32 years
|
Baseline, after 3 months, after 12 months, then annually until the end of the study. Currently there is a follow-up of 32 years
|
|
|
Name of the contact person
時間枠：Baseline, after 3 months, after 12 months, then annually until the end of the study. Currently there is a follow-up of 32 years
|
Baseline, after 3 months, after 12 months, then annually until the end of the study. Currently there is a follow-up of 32 years
|
|
|
Telephone number of the contact person
時間枠：Baseline, after 3 months, after 12 months, then annually until the end of the study. Currently there is a follow-up of 32 years
|
Baseline, after 3 months, after 12 months, then annually until the end of the study. Currently there is a follow-up of 32 years
|
|
|
Relationship between the patient and the contact person
時間枠：Baseline, after 3 months, after 12 months, then annually until the end of the study. Currently there is a follow-up of 32 years
|
Baseline, after 3 months, after 12 months, then annually until the end of the study. Currently there is a follow-up of 32 years
|
|
|
Date of birth
時間枠：Baseline
|
as date |
Baseline
|
|
Date of death
時間枠：After 3 months, after 12 months, then annually until the event occurs. Currently there is a follow-up of 32 years-up
|
as date |
After 3 months, after 12 months, then annually until the event occurs. Currently there is a follow-up of 32 years-up
|
|
Living arrangements
時間枠：Baseline, after 3 months, after 12 months, then annually until the end of the study. Currently there is a follow-up of 32 years
|
Which kind of living arrangement (own home environment, assisted living, nursing home) and who are the people, who live in this arrangement (alone, spouse, children, relatives, others) |
Baseline, after 3 months, after 12 months, then annually until the end of the study. Currently there is a follow-up of 32 years
|
|
Assistance
時間枠：Baseline, after 3 months, after 12 months, then annually until the end of the study. Currently there is a follow-up of 32 years
|
yes/ no |
Baseline, after 3 months, after 12 months, then annually until the end of the study. Currently there is a follow-up of 32 years
|
|
National Institutes of Health Stroke Scale (NIHSS)
時間枠：Baseline, after 3 months, after 12 months, then annually until the end of the study. Currently there is a follow-up of 32 years
|
Total Score Range: 0-42 (15 items, each scored on 3-5 point ordinal grades, 0 = normal), higher values indicate greater stroke severity (0 = no stroke symptoms, 1-4 minor, 5-15 moderate, 16-20 moderate-to-severe, 21-42 severe) |
Baseline, after 3 months, after 12 months, then annually until the end of the study. Currently there is a follow-up of 32 years
|
|
(Modified) Rankin Scale
時間枠：Baseline, after 3 months, after 12 months, then annually until the end of the study. Currently there is a follow-up of 32 years
|
Total Score Range: 0-6 (7-point ordinal disability scale), higher values indicate worse (higher) disability (0 = no symptoms, 1 = no significant disability, 2 = slight disability, 3 = moderate disability, 4 = moderately severe disability, 5 = severe disability, 6 = death) |
Baseline, after 3 months, after 12 months, then annually until the end of the study. Currently there is a follow-up of 32 years
|
|
Mini-Mental State Examination (MMSE)
時間枠：Baseline, after 3 months, after 12 months, then annually until the end of the study. Currently there is a follow-up of 32 years
|
Total Score Range: 0-30, higher values indicate better cognitive performance |
Baseline, after 3 months, after 12 months, then annually until the end of the study. Currently there is a follow-up of 32 years
|
|
Medication
時間枠：Baseline, after 3 months, after 12 months, then annually until the end of the study. Currently there is a follow-up of 32 years
|
Name of the drug |
Baseline, after 3 months, after 12 months, then annually until the end of the study. Currently there is a follow-up of 32 years
|
|
Medication
時間枠：Baseline, after 3 months, after 12 months, then annually until the end of the study. Currently there is a follow-up of 32 years
|
Quantity |
Baseline, after 3 months, after 12 months, then annually until the end of the study. Currently there is a follow-up of 32 years
|
|
Medication
時間枠：Baseline, after 3 months, after 12 months, then annually until the end of the study. Currently there is a follow-up of 32 years
|
Dose in milligrams per day |
Baseline, after 3 months, after 12 months, then annually until the end of the study. Currently there is a follow-up of 32 years
|
|
Charlson Comorbidity Index (CCI)
時間枠：Baseline, after 3 months, after 12 months, then annually until the end of the study. Currently there is a follow-up of 32 years
|
Total Score Range: 0-33, higher values indicate a worse (greater) comorbid disease burden |
Baseline, after 3 months, after 12 months, then annually until the end of the study. Currently there is a follow-up of 32 years
|
|
Hypertension
時間枠：Baseline, after 3 months, after 12 months, then annually until the end of the study. Currently there is a follow-up of 32 years
|
yes/ no |
Baseline, after 3 months, after 12 months, then annually until the end of the study. Currently there is a follow-up of 32 years
|
|
Diabetes mellitus
時間枠：Baseline, after 3 months, after 12 months, then annually until the end of the study. Currently there is a follow-up of 32 years
|
yes/ no |
Baseline, after 3 months, after 12 months, then annually until the end of the study. Currently there is a follow-up of 32 years
|
|
Hypercholesterinemia
時間枠：Baseline, after 3 months, after 12 months, then annually until the end of the study. Currently there is a follow-up of 32 years
|
yes/ no |
Baseline, after 3 months, after 12 months, then annually until the end of the study. Currently there is a follow-up of 32 years
|
|
TOAST-Classification
時間枠：Baseline, after 3 months, after 12 months, then annually until the end of the study. Currently there is a follow-up of 32 years
|
Categorical etiologic classification system; it sorts ischemic stroke into 5 mutually exclusive subtype categories: (1) large-artery atherosclerosis, (2) cardioembolism, (3) small-vessel occlusion (lacunar), (4) stroke of other determined etiology, and (5) stroke of undetermined etiology |
Baseline, after 3 months, after 12 months, then annually until the end of the study. Currently there is a follow-up of 32 years
|
|
Medical Outcomes Study Social Support Survey (MOS-SSS)
時間枠：Baseline, after 3 months, after 12 months, then annually until the end of the study. Currently there is a follow-up of 32 years
|
Total Score Range: Raw sum score: 19-95 (19 items, each rated on the 5-point frequency scale: 1 = none of the time … 5 = all of the time), Transformed index (0-100 scale), higher values indicate better (greater) perceived/available social support |
Baseline, after 3 months, after 12 months, then annually until the end of the study. Currently there is a follow-up of 32 years
|
|
Short Form 36 Health Survey (SF-36)
時間枠：Baseline, after 3 months, after 12 months, then annually until the end of the study. Currently there is a follow-up of 32 years
|
Physical health and mental health summary scores, Total Score Range: 0-100, norm-based scoring, higher values indicate a better physical/mental health status |
Baseline, after 3 months, after 12 months, then annually until the end of the study. Currently there is a follow-up of 32 years
|
|
Barthel Index
時間枠：Baseline, after 3 months, after 12 months, then annually until the end of the study. Currently there is a follow-up of 32 years
|
Total Score Range: 0-100, higher values indicate better functional independence (less disability) |
Baseline, after 3 months, after 12 months, then annually until the end of the study. Currently there is a follow-up of 32 years
|
|
Frenchay Activities Index (FAI)
時間枠：Baseline, after 3 months, after 12 months, then annually until the end of the study. Currently there is a follow-up of 32 years
|
Total Score Range: 15-60, higher values indicate better (greater) frequency/independence in instrumental activities of daily living (IADL) |
Baseline, after 3 months, after 12 months, then annually until the end of the study. Currently there is a follow-up of 32 years
|
|
Functional Independence Measure (FIM)
時間枠：Baseline, after 3 months, after 12 months, then annually until the end of the study. Currently there is a follow-up of 32 years
|
Total Score Range: 18-126, Subscales: FIM-motor 13-91, FIM-cognitive 5-35, higher values indicate better (greater) functional independence (18 = total dependence, 126 = total independence) |
Baseline, after 3 months, after 12 months, then annually until the end of the study. Currently there is a follow-up of 32 years
|
協力者と研究者
出版物と役立つリンク
研究記録日
主要日程の研究
研究開始 (実際)
一次修了 (推定)
研究の完了 (推定)
試験登録日
最初に提出
QC基準を満たした最初の提出物
最初の投稿 (実際)
学習記録の更新
投稿された最後の更新 (実際)
QC基準を満たした最後の更新が送信されました
最終確認日
詳しくは
本研究に関する用語
追加の関連 MeSH 用語
その他の研究ID番号
- 249_15 Bc
- DRKS00040516 (レジストリ識別子：German Clinical Trials Register)
- ZMV I 1-2520KEU305 (その他の助成金/資金番号：German Federal Ministry of Health (BMG))
個々の参加者データ (IPD) の計画
個々の参加者データ (IPD) を共有する予定はありますか?
IPD プランの説明
Information on the use of research data from the Erlangen Stroke Registry can be found on the website at the following link: https://www.izph.fau.de/projekte/erlanger-schlaganfallregister/#angebot-zur-nutzung-von-forschungsdaten-aus-dem-erlanger-schlaganfallregister
医薬品およびデバイス情報、研究文書
米国FDA規制医薬品の研究
米国FDA規制機器製品の研究
この情報は、Web サイト clinicaltrials.gov から変更なしで直接取得したものです。研究の詳細を変更、削除、または更新するリクエストがある場合は、register@clinicaltrials.gov。 までご連絡ください。 clinicaltrials.gov に変更が加えられるとすぐに、ウェブサイトでも自動的に更新されます。